Respiratory Mechanics in Brain Injured Patients

Università degli Studi dell'Insubria

Status: Unknown

Conditions: Brain Injury; Acute Lung Injury

Treatments: Other: PEEP

Study type: Interventional

Funder types: Other

Identifiers

NCT00639990

No financial support

003

Details and patient eligibility

About

The hypothesis is that brain injury patients have alterations of the respiratory system related to intraabdominal pressure. Furthermore application of moderate levels of PEEP may improve respiratory function in these patients.

Full description

We investigate the mechanical properties of the respiratory system, partitioned into its lung and chest wall components, the functional residual capacity, the gas-exchange and alveolar recruitment in brain injured patients.

The measurements will be performed under sedation at different levels of PEEP. The following groups will be included: a) control patients withot lung injury and brain injury; b) brain injured patients without lung injury within the first 72 hours; c) brain injured patients without lung injury after 72 hours; d) brain injured patients with lung injury. Brain injury was defined as primary or secondary. Respiratory functional data will be related to intra-abdominal pressure.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and Female
• Age > 18 yrs
• Mechanical ventilation
• No smoker
• No lung injury at entry
• Brain injury (traumatic or postoperative or spontaneous bleeding) in brain injury group

Exclusion criteria

• Pregnancy
• Hemodynamic instability
• Immunodepression

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Control

Active Comparator group

Description:

Patients without lung injury and brain injury

Treatment:

Other: PEEP

Other: PEEP

Other: PEEP

Other: PEEP

Brain No ALI 1

Experimental group

Description:

Patients with brain injury and no lung injury within 72 hours from ICU entry

Treatment:

Other: PEEP

Other: PEEP

Other: PEEP

Other: PEEP

Brain No ALI 2

Experimental group

Description:

Patients with brain injury and no ALI after 72 hours from ICU entry

Treatment:

Other: PEEP

Other: PEEP

Other: PEEP

Other: PEEP

Brain ALI

Experimental group

Description:

Patients with brain injury and Acute Lung Injury (ALI)

Treatment:

Other: PEEP

Other: PEEP

Other: PEEP

Other: PEEP